The aim of the study is to investigate the effect of dietary supplements such as probiotic, prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota in adult healthy volunteers.

Double-blind, Placebo Controlled Randomized Parallel Study to Determine the Effects of Pre-pro and Synbiotic Administration on the Immune Response to Influenza Vaccination and Faecal Microbiota in Healthy Adults

Further study details as provided by University of Reading:

Primary Outcome Measures:

The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group. [ Time Frame: 2 and 4 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities. [ Time Frame: at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment ] [ Designated as safety issue: No ]

Group of 25 volunteers consuming placebo product once a day for 7 weeks

Dietary Supplement: Placebo

Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks

Detailed Description:

Within recent times, influenza has become a major respiratory infection worldwide. The preventative vaccination reduces the severity of infection but ageing reduced its efficacy and it is only effective in 17-53% in elderly individuals. Thus, nutritionists and medical researchers are looking for opportunities to improve the immune response to influenza vaccine. Functional foods, such as probiotics, prebiotics and synbiotics, apart from other health benefits, may contribute towards immune protection.

Probiotics are beneficial bacteria, which are regarded as safe and serve health benefits to the host, while prebiotics are carbohydrates which by escaping digestion in the upper gastrointestinal tract may reach the colon and there serve as food for beneficial bacteria in the colon. When prebiotic used in combination with probiotic bacteria, it is called synbiotic, and it may improve survival and implantation of probiotic in the gut.

The human study will examine the immune response to vaccination and changes in faecal microbiota during administration of probiotic, prebiotic and synbiotic supplements. The study will be conducted between vaccinations seasons in 2010-2011 and recruit 100 healthy subjects aged 40-65years old. Participant will be given one of four different treatments over a 7 week period following 3 weeks of wash-out period. Treatments given include: a probiotic, a prebiotic, a synbiotic and a placebo. In the 3rd week of product consumption the participant will be given a flu jab. Specific antibody titre against the 3 viral strains composing the vaccine and total immunoglobulin concentration in the serum will be monitored during 2 and 4 weeks after vaccination. Faecal samples and saliva will be collected and analysed for changes in faecal microbial populations.

Eligibility

Ages Eligible for Study:

45 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Signed consent form

Age 40-65 years

Body mass index 18.5-30 inclusive

Good general health as determined by medical questionnaires

Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine

Exclusion Criteria:

Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study

History of drug misuse, including alcohol

Allergy to the vaccine

Asplenia and other acquired or congenital immunodeficiency

Severe allergy such as asthma, hay-fever, dermatitis or being treated on these

Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study

Use of prescribed medication

Regular use of aspirin or other anti-inflammatory drugs

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084434